Taytulla – Birth Control Pill Recall

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules.
 
Allergan issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6×28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.

Incorrectly Packaged TAYTULLA

As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the capsules out of order. If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician.

This product is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives. The TAYTULLA  pill pack is a 28 count blister card that has 24 “active” pink softgel capsules (with hormones) with “WC” printed on the outer shell in white to be taken for 24 days, followed by 4 maroon softgel capsules (without hormones) also imprinted with “WC” on one side to be taken for the next four days. If you are a patient in the U.S. who has used a TAYTULLA sample pack from lot 5620706, Exp. May 2019 since August 27, 2017, and are concerned that you may be impacted by this issue, please consult with your physician. This product was distributed Nationwide to healthcare providers.

Please refer to the affected lot number as well as the pictures below of the affected product.

Allergan is notifying customers by recall letter and is arranging for return of all recalled sample pack product with the lot #5620706 Exp. May 2019. Consumers who have the sample pack product with the associated lot number should notify their physician to arrange a return.  

Consumers with questions regarding this recall can contact Allergan by phone at 800-678-1605 8am-8pm EST Monday through Friday. Consumers should contact their physician or healthcare provider if they have questions.

For more information about TAYTULLA and the full prescribing information, please visit www.taytulla.com.

Company Contact:  1-800-678-1605

Correctly Packaged TAYTULLA

Your Safety and Well-being is our Priority

On behalf of all of us at Women’s Health Partners, in these difficult times, we want to thank you for your support and confidence in our practice.

We want you to personally know that our patients’ health and well-being has and always will be our number one priority. This reminder bears repeating in the face of any challenges and especially now, given concerns posed by the corona virus (COVID-19) pandemic.

We are taking all necessary precautions to ensure your safety and well-being and that of our staff. To that end, we want to share some of the steps we are taking:

Furthermore, our staff will be asking several screening questions regarding your health. We ask that you do not enter our office if you, or someone in your family, or someone you recently were in contact with, has exhibited flu-like symptoms such as fever, cough, shortness of breath, severe muscle aches, shaking chills, or recent loss of taste or smell, or recently diagnosed with COVID19.

In order to help us participate with our social distancing effort, we are asking patients to enter the office without any visitors, including children.

You will also have the option of waiting in your car instead of the waiting room after you have checked in. The front desk staff will call your cell phone when we are ready for you to come in for your visit.

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